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Updated clinical development strategy based on positive data

In the third quarter of 2025, Mendus shaped up its clinical development plans for the lead program vididencel in myeloid malignancies.

The updated clinical strategy positions vididencel more broadly as a post-remission therapy in acute myeloid leukemia (AML) and includes chronic myeloid leukemia (CML) as an additional indication. The ambitious plan is based on our continued positive data with vididencel in AML and follows the recent appointment of Tariq Mughal as Chief Medical Officer. Mendus also announced a corporate reorganization to offset new clinical trial expenses. In its earlier stage pipeline, Mendus reported the granting of a US patent covering the use of vididencel in ovarian cancer following positive clinical data presented at ASCO and a preclinical collab­oration in AML with an international biopharmaceutical company. 

 

Erik Manting, CEO

The Phase 2a ADVANCE II trial studies vididencel as a post-remission monotherapy following high-intensity chemotherapy in high-risk AML, with all patients having measurable residual disease (MRD) at study entry. In the most recent read-out, the majority of patients treated were alive and disease-free at 48 months median follow-up. In the randomized Phase 2b AMLM22-CADENCE trial, vididencel is combined with oral azacitidine, which is currently licensed for maintenance treatment, in adults patients with AML in CR1 following intensive chemotherapy induction, irrespective of their MRD status. The trial, supported by the Australasian Leukaemia and Lymphoma Group (ALLG), broadens the positioning of vididencel beyond MRD-positive patients and significantly expands its target population. Early October, Mendus reported that 12 patients had been enrolled in the CADENCE trial, with the goal to reach 20 in the first quarter of 2026.

As part of its strategy to position vididencel broadly in AML, Mendus has prepared a Phase 1b (DIVA) trial to evaluate vididencel as an adjunct immunotherapy for patients receiving frontline induction therapy with venetoclax and azacitidine (Ven-Aza), currently considered the standard-of-care frontline therapy for AML patients unfit for intensive therapy. However, this combination is far from curative, creating a growing patient population in need of novel treatments to prevent disease relapse without adding toxicity. Following our promising preclinical data of combining vididencel with Ven-Aza presented at ASH 2024, there was considerable enthusiasm from global AML experts to test this strategy in the clinics. Initial topline data from both CADENCE and DIVA trials are expected mid-2026 and will inform the go-to-market strategy for vididencel in AML.

In the third quarter of 2025, Mendus has also entered into a preclinical research collaboration with an international biopharmaceutical company to study vididencel in combination with targeted therapy in AML.

Building on the durable clinical responses and robust safety profile observed in AML, Mendus will initiate clinical development of vididencel in chronic phase CML. While tyrosine kinase inhibitors (TKIs) transformed CML from a fatal disease to a chronic condition, most patients require lifelong therapy, which carries risks of toxicity, serious adverse events, and significant impact on the quality of life; it is also considerably expensive. The notion of a ‘treatment-free-remission’ (TFR) has therefore been considered important in CML and has been tested with modest success. Based on the convincing demonstration that an immune effect plays a central role in eliminating MRD after an allograft. Furthermore, our preclinical data presented at ASH 2024, supports this concept and the potential for vididencel in CML, first to facilitate TFR safely and second to maintain TFR effectively. Initial Phase 1a/b safety data are expected mid-2026, to support the start of a Phase 2a trial evaluating vididencel in patients who previously failed TFR attempts.

In its earlier-stage pipeline, Mendus was granted a patent covering the use of vididencel in ovarian cancer by the United States Patent and Trademark Office (USPTO). This further validated the potential of vididencel as an active immunotherapy in this indication, following positive clinical data presented at the ASCO 2025 conference from the Phase 1 ALISON trial carried together with the University Medical Center Groningen (UMCG). The next read-out of the ALISON trial based on 2-year follow-up is anticipated in the fourth quarter of 2025. Mendus and UMCG also presented data confirming the use of Mendus’ proprietary DCOne platform for the expansion of tumor-infiltrating lymphocytes (TILs) at the SITC 2025 conference. The data showed superior expansion and functionality of TILs in the presence of DCOne-derived dendritic cells, as a basis for TIL-based treatment of ovarian cancer and potentially other solid tumors.

In conjunction with the increased focus on execution of its clinical strategy, Mendus has announced a reduction of its staff, including the company’s executive management team. The cost savings realized by the corporate reorganization are estimated to offset the extra trial costs anticipated for 2026.

With the updated clinical strategy in place, Mendus is in a strong position to capture the vididencel opportunity in myeloid malignancies, with multiple milestones anticipated in 2026. The durable remissions associated with vididencel treatment, combined with an excellent safety profile may allow AML and CML patients to experience longer periods of treatment-free survival. We look forward to keeping our stakeholders updated of our progress towards this ultimate goal.

Erik Manting, Ph.D.
Chief Executive Officer

 

*Published on November 13, 2025